(233 days)
The High Tibial Osteotomy System is indicated for fixation of high tibial osteotomy.
The High Tibial Osteotomy System consists of a pre-contoured plate and self-tapping screws in various sizes for high tibial osteotomy. The plates and screws are manufactured from titanium alloy and color anodized. The High Tibial Osteotomy System will be provided sterile.
This document is a 510(k) premarket notification for a medical device (High Tibial Osteotomy System), not a study report for an AI/ML powered device. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML application.
Specifically, the document states:
- "No clinical studies were performed." (Page 4, Section 8, "Clinical Test Summary:")
- It refers to "Non-clinical Test Summary" which lists "Comparative fatigue compression tests," "Comparative static compression tests," "Geometric analysis of the subject and predicate screws," and "Torsional engineering analysis of plates." These are engineering and material tests, not performance studies for an AI/ML algorithm.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this document.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.